MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS, EUROPE; LEFT VENTRICULAR ASSIST DEVICE

Catalog Number 102139

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/06/2015

Event Type  Injury  

Event Description

The patient was implanted with a left ventricular assist device (lvad).It was reported that the patient presented to the hospital for a routine follow-up with no reported symptoms.A routine chest x-ray revealed that the outflow graft was fine; however, the outflow graft bend relief was disconnected.The patient is slim and participates in endurance sports (marathon skater).The outflow graft and outflow graft bend relief were exchanged.No additional information was received.

Manufacturer Narrative

The patient age was not provided.Approximate age of device: 6 years.The outflow graft was returned for analysis.The evaluation is not complete.No further information is available.A supplemental report will be submitted when the manufacturer's investigation is completed.

Manufacturer Narrative

The disconnect of the outflow graft and bend relief was confirmed by the x-ray provided.The outflow graft conduit was returned with approximately 6 inches of graft material.Two holes in the graft material were identified adjacent to the graft attachment hardware.The edges of these holes were frayed, which is consistent with wear associated with the graft material rubbing against a disengaged bend relief attachment clip.Additionally, the distal edge of the graft attachment hardware next to the observed holes revealed wear that was also indicative of abrasion.Approximately 4 inches of the bend relief was returned detached from the outflow graft.The locking tabs of the bend relief were aligned with the body of the attachment clip.These tabs showed no indication that they had ever been bent or pried; however, one of the locking tabs revealed wear consistent with abrasion against the graft attachment hardware.The returned outflow graft and bend relief were sent to an independent laboratory for additional analysis.Their evaluation of the returned product revealed that wear between the locking tabs on the bend relief and the mating lip of the outflow graft nut allowed the tabs to release their grip over time.The likely wear mechanisms were identified as galling and fretting corrosion.Of note, it was reported that the patient is slim and participates in endurance sports, specifically marathon skating.A review of device history records showed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing its file on this event.

• Brand Name: HEARTMATE II LVAS, EUROPE
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: robert fryc ; 23 fourth avenue; burlington, MA 01803 ; 781272-013
• MDR Report Key: 4962699
• MDR Text Key: 17691069
• Report Number: 2916596-2015-01397
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2012
• Device Catalogue Number: 102139
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2015
• Initial Date FDA Received: 08/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 60